Vedolizumab, a monoclonal antibody has a higher 1- and 2-year persistence compared to two tumor necrosis factor inhibitors (anti-TNF, TNFi) in both Crohn’s disease and ulcerative colitis, according to the results of a meta-analysis. The result mainly affects bionaive patients; the advantage of vedolizumab over the two TNFis—infliximab and adalimumab—was more pronounced in ulcerative colitis than in Crohn’s disease.»It appears that patients are more likely to maintain treatment with vedolizumab than with infliximab or adalimumab, especially in bionaïve patients, which could indicate either better tolerability of treatment or better response,» said Dr Tsz Hong Yiu (University of Sydney) at the annual congress of the European Crohn’s and Colitis Organisation.
The 2-year follow-up data are particularly encouraging, Yiu said, as more patients continued treatment with vedolizumab in both ulcerative colitis and Crohn’s disease than with both anti-TNF-alpha drugs combined.
In a direct comparison, 15% more patients continued to take vedolizumab at 1-year follow-up for both ulcerative colitis and Crohn’s disease than anti-TNF-alpha drugs overall (risk ratio 1.15). At 2-year follow-up, 12% more patients continued treatment with vedolizumab than with anti-TNF-alpha drugs overall (RR 1.12), again for both forms of inflammatory bowel disease (IBD).
«This may provide initial evidence that vedolizumab is suitable as a first-line biological therapeutic for inpatients with inflammatory bowel disease,» Yiu said, noting that further research is needed to validate the correlation between persistence and clinical efficacy.
The first author of the study, Dr. Rupert Leong, a gastroenterologist at Concord RepatriaKon General Hospital in Sydney, explained the motivation for the study: «We wanted to identify the drug with the highest effectiveness, i.e.h. the real benefit of the drug for patients, and not the efficacy, which refers to clinical trial data. Importantly, data from clinical trials usually span only one year, whereas data from persistence studies are often collected over several years. This is important in chronic diseases that can affect patients over several decades, as the true benefit of a drug cannot be derived from a short-term clinical trial,» Leong explained.
Persistence was chosen as the primary endpoint because it is a measure of a drug’s efficacy and side effect profile, but also of the patient’s perspective, Dr. Yiu added. «Thus, a patient can put mild side effects above the effectiveness of the treatment and decide to stop treatment.»
A earlier meta-analysis dealing with response loss found that 33% of patients taking infliximab and 41% of patients taking adalimumab became resistant to the biologics after a median follow-up of one year.»The most common cause of loss of response to anti-TNF inhibitors is immunogenicity,» Yiu noted. «These results suggest that alternative biologics with high efficacy should be considered.»
The data from the 2019 VARSITY study also formed the basis for the scientists’ decision to conduct a real-world study. The researchers of the VARSITY study found that vedolizumab had higher efficacy than adalimumab in ulcerative colitis; However, data on the real-world effectiveness of vedolizumab compared to adalimumab and infliximab in both ulcerative colitis and Crohn’s disease remained unknown.
Leong pointed out the difficulty of selecting the right treatment in view of the increasing number of biologics available. «The lack of head-to-head studies means that the use of cohort studies is considered relevant and informative, not least because long-term follow-up data may reveal the secondary loss of response to these monoclonal antibodies, while merging data further increases statistical power and determines consistency.»
Therefore, the scientists conducted a systematic review and meta-analysis of six observational studies investigating persistence as a surrogate marker for clinical response of vedolizumab compared to infliximab and adalimumab in participants over 18 years of age with a diagnosis of ulcerative colitis or Crohn’s disease from 2017 to July 2022.
Overall, the study found that the 1-year persistence of vedolizumab was 71.2% for ulcerative colitis and 76% for Crohn’s disease, which was significantly higher than infliximab (56.4% for ulcerative colitis, 53.7% for Crohn’s disease), and also for adalimumab (53.7% for ulcerative colitis, 55.6% for Crohn’s disease).
The results of 2-year persistence were pooled from four studies and found that vedolizumab had 2-year persistence of 66% in ulcerative colitis and 61% in Crohn’s disease.For comparison, infliximab had persistence of 49.7% in ulcerative colitis and 59.1% in Crohn’s disease, and adalimumab had persistence of 31.4% in ulcerative colitis and 56% in Crohn’s disease. Especially in ulcerative colitis, vedolizumab performed better than adalimumab and infliximab. In particular, in Crohn’s disease, vedolizumab had slightly higher 1-year persistence than the anti-TNF inhibitors combined (RR 1.10; 95% CI 1.02-1.19), but there were insufficient data for individual analysis.
In a subgroup of bionaïve patients, vedolizumab had a higher 1-year persistence (RR 1.14; 95% CI 1.07-1.22), but showed no statistically significant benefit in bioexperienced patients compared to anti-TNF inhibitors (RR 1.04; 95% CI 0.80-1.35).
Yiu noted that at the time of their systematic review, they could not find any randomized controlled trials (RCTs) that directly compare infliximab to vedolizumab in IBD. However, he pointed to a recent Research article comparing the efficacy, persistence and adverse event profile of vedolizumab and infliximab in a small cohort of ulcerative colitis patients.»In this study, vedolizumab was overall superior to infliximab, which is consistent with the results of our study.»
Dr. Viraj Kariyawasam, gastroenterologist and head of the IBD department at Blacktown and Mount Druitt Hospital in Sydney, commented on the study, saying the findings were «very important in defining the role of vedolizumab in the treatment of ulcerative colitis and Crohn’s disease in particular.» And: «Although vedolizumab is considered by most practicing physicians to be a less effective drug in Crohn’s disease compared to infliximab and anti-TNFs are still preferred in the treatment of Crohn’s disease, the study highlights the superior persistence of vedolizumab. This is probably related to efficacy against the two most commonly used anti-TNF agents. Given the evidence of reduced efficacy of vedolizumab following the use of anti-TNFs or as a second- or third-line agent and the superior persistence of vedolizumab as a first-line biologic with previously published safety data, vedolizumab should be considered and preferred as a first-line agent in the treatment of ulcerative colitis and Crohn’s disease.»
This article originally appeared on MDedge.com, part of the Medscape Professional Network.It was translated by Dr. Petra Kittner.
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